BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3349947 · Received September 16, 2013

    Report

    Report Number
    2939301-2013-02933
    Event Type
    Injury
    Date Received
    September 16, 2013
    Report Date
    September 5, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (10/09/2013).THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/26/2013 AND 10/1/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE BECAUSE HIS ONETOUCH PING METER WAS NOT POWERING ON. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013, AT 10AM. THE REPORTER STATED THE PATIENT USES INSULIN PUMP THERAPY TO MANAGE HIS DIABETES. THE REPORTER STATED THE PATIENT MADE NO CHANGES TO HIS USUAL DIABETES ROUTINE. THE REPORTER STATED ABOUT 3 HOURS LATER THE PATIENT DEVELOPED SYMPTOMS OF ¿CONFUSED, THIRSTY AND HUNGRY¿ WHICH WERE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE REPORTER STATED THE PATIENT WAS GIVEN GLUCOSE TABLETS ON (B)(6) 2013, AT 1PM, AS TREATMENT. THE REPORTER STATED ON (B)(6) 2013, AT 2:30PM, A BLOOD GLUCOSE READING OF ¿74MG/DL¿ WAS OBTAINED ON A ONETOUCH ULTRAMINI METER. AT THE TIME OF TROUBLE SHOOTING, THE CCA NOTED THAT THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE PRODUCT. THE CCA NOTED THAT THE BATTERY DID NOT NEED REPLACING. THE PATIENT WAS FOUND TO BE USING THE CORRECT TEST STRIPS. WHEN A NEW TEST STRIP WAS INSERTED, THE METER DID NOT TURN ON. WHEN THE POWER BUTTON WAS PRESSED, THE METER DID NOT TURN ON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464128 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R